Description
Syneos Health is seeking a CRA II or Senior CRA to work in a home-based setting in Lithuania. The successful candidate will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits. They will also verify the process of obtaining informed consent, assess factors that might affect subject/patient's safety and clinical data integrity, and document activities via confirmation letters, follow-up letters, trip reports, and other required project documents.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits
- Verify the process of obtaining informed consent
- Assess factors that might affect subject/patient's safety and clinical data integrity
- Document activities via confirmation letters, follow-up letters, trip reports, and other required project documents
- Manage site-level activities and communication to ensure project objectives, deliverables, and timelines are met
- Provide guidance at the site and project level towards audit readiness standards
- May act as primary liaison with study site personnel
- May provide direct supervision, training, and/or mentorship to more junior level CRAs
Qualifications:
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent communication, presentation, and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis